Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

Phase 2 Terminated 648 enrolled Spectrum Pharmaceuticals, Inc

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).

Timeline

Start: 2017-10-11
Primary completion: 2023-04-03
Completion: 2023-04-03

Publications

Le X, Cornelissen R, Garassino M, Clarke JM, Tchekmedyian N, Goldman JW, Leu SY, Bhat G, Lebel F, Heymach JV, Socinski MA. Poziotinib in Non-Small-Cell Lung Cancer Harboring HER2 Exon 20 Insertion Mutations After Prior Therapies: ZENITH20-2 Trial. J Clin Oncol. 2022 Mar 1;40(7):710-718. doi: 10.1200/JCO.21.01323. Epub 2021 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Poziotinib	Small molecule	6 mg	Oral
Subject	Poziotinib	Small molecule	8 mg	Oral
Subject	Poziotinib	Small molecule	10 mg	Oral
Subject	Poziotinib	Small molecule	12 mg	Oral
Subject	Poziotinib	Small molecule	16 mg	Oral

Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

Summary

Timeline

Publications

Drugs

Indications